INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00615134

Purpose

This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon + optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to receive either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s.c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with Fuzeon, in the case of new virological failure. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Condition	Intervention	Phase
HIV Infections	Drug: enfuvirtide [Fuzeon] Drug: Optimized background ARV therapy	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-Naive HIV-1 Infected Patients With Virological Failure.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients with plasma viral load <50 copies/mL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
1: Experimental	Drug: enfuvirtide [Fuzeon] 90mg sc bid Drug: Optimized background ARV therapy As prescribed
2: Active Comparator	Drug: Optimized background ARV therapy As prescribed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
HIV-1 infection, with virologic failure;
on same stable HAART for >4 weeks, with viral load >1000 RNA copies/mL;
Fuzeon-naive.

Exclusion Criteria:

coinfection with HIV-2;
active opportunistic infection in 4 weeks prior to screening;
cirrhosis or severe liver failure;
severe renal disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615134

Contacts

Contact: Please reference Study ID Number: ML21287	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

France
	Recruiting
NANTES, France, 44035
	Recruiting
NICE, France, 06202
	Recruiting
TOULOUSE, France, 31052
	Recruiting
GARCHES, France, 92380
	Recruiting
NIMES, France, 30029
	Recruiting
LEVALLOIS PERRET, France, 92309
	Recruiting
TOURCOING, France, 59208
	Recruiting
POITIERS, France, 86021
	Recruiting
FORT-DE-FRANCE, France, 97261
	Recruiting
BASSE-TERRE, France, 97100
	Recruiting
SAINT PIERRE, France, 97448
	Recruiting
SAINT-DENIS, France, 97400
	Recruiting
PARIS, France, 75970
	Not yet recruiting
TOULOUSE, France, 31059
	Recruiting
ROUEN, France, 73031
	Recruiting
CAEN, France, 14033
	Recruiting
MARSEILLE, France, 13006
	Recruiting
LA ROCHE SUR YON, France, 85925
	Recruiting
PONTOISE, France, 95303
	Recruiting
PARIS, France, 75010
	Terminated
BOULOGNE, France, 62321
	Recruiting
AULNAY SOUS BOIS, France, 93600
	Recruiting
BORDEAUX, France, 33000
	Recruiting
PESSAC, France, 33600
	Recruiting
PARIS, France, 75014
	Recruiting
PARIS, France, 75674
	Recruiting
POINTE À PITRE, France, 97159
	Terminated
Colmar, France, 68024
	Recruiting
LE KREMLIN BICÊTRE, France, 91275
	Recruiting
PARIS, France, 75651
	Recruiting
PARIS, France, 75571
	Terminated
LYON, France, 69317

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21287
Study First Received:	January 30, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00615134
Health Authority:	France:Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Keywords provided by Hoffmann-La Roche:

treatment experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Enfuvirtide
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Infection

Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009